NCT00311610已完成2 期
Phase II Trial of LE SN38 in Patients With Metastatic Colorectal Cancer After Progression on Oxaliplatin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Objective response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate following treatment with SN-38 liposome as a second-line treatment in patients with metastatic colorectal cancer.
Secondary
- Determine the toxicity profile of this drug in these patients.
- Determine the proportion of patients treated with this drug who experience any grade 3 or greater toxicity.
- Determine progression-free survival and overall survival for patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SN-38 liposome
Experimental
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for up to 3 years.
干预措施: SN-38 liposome (Drug)
结局指标
主要结局
Objective response rate
时间窗: q 2 cycles during tx
次要结局
- Toxicity(q cycle during tx)
- Progression-free survival(3 years)
- Overall survival(3 years)
研究者
研究点 (10)
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